3.9. Post-Market Surveillance
Process that defines the requirements for the Post-Market Surveillance (PMS) review and evaluation of the medical device’s continued safety and performance to assure that all post-market surveillance-related information is effectively collected, summarized and reported within Quality Management System for medical device products.
MDR Reporting
Complaint Handling
Reporting of any adverse events or product issues to the relevant regulatory authorities.
Investigating and addressing any customer complaints or concerns related to the medical device.